COVID-19 Disease Duration and GIT Manifestations. A New Disease Severity Classification. An Egyptian Experience

NCT ID: NCT04554979

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-07-15

Brief Summary

The present study conducted to correlate symptoms not only constitutional and respiratory, but GIT as a principle presentation, with laboratory markers and COVID-19 severe acute respiratory syndrome (SARS-COV2) disease outcomes, as the duration of symptoms varies substantially between patients; the investigators undertook this study to determine the optimal time to predict COVID-19 outcomes based on real-time experience.

Detailed Description

This observational retrospective cohort single center national study was conducted on patients who tested positive COVID-19 infection by the polymerase chain reaction (PCR) of nasopharyngeal sample in the period from first June to the med of July 2020. Patients were recruited from Kasr Al-Aini School of medicine, COVID-19 out-patient clinic, Cairo University hospitals.

The diagnosis and classification of severity of COVID-19 infection were made according to the clinical management of COVID-19, released by the World Health Organization (WHO), mild and moderate case were recruited, the treatment protocol used was according to the Egyptian ministry of health treatment recommendations, which met in part the criteria that was later on published by the national institute of health, Mild and moderate cases once diagnosed by PCR received hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started till result of sputum culture and sensitivity. Steroids were initiated in hypoxic cases that required supplemental oxygen and in cases of persistent symptoms.

Any adult patient (age ≥18 years) suffering from mild or moderate COVID-19 infection was included in this study. While severe cases according to WHO classifications and patients aged less than18 were excluded from the study.

Conditions

Covid19; Diarrhea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1

Duration of COVID-19 symptoms less than 12 days

Hydroxychloroquine Pill

Intervention Type: DRUG

hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started

Group 2

Duration of COVID-19 symptoms equal or more than 12 days

Hydroxychloroquine Pill

Intervention Type: DRUG

hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started

Interventions

Hydroxychloroquine Pill

hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started

Intervention Type: DRUG

Other Intervention Names

corticosteroids; anticoagulant; antibiotic; vitamin c pill; zinc pill

Eligibility Criteria

Inclusion Criteria

• Mild and moderate COVID-19 patients:

Exclusion Criteria

• Age less than 18 years
• Severe COVID-19 patients: with dyspnea, hypoxia, or >50 percent lung involvement on imaging within 24 to 48 hours
• Critical COVID-19 patients: with respiratory failure, shock, or multiorgan dysfunction

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mona Hegazy

Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona M Hegazy, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University

Ahmed M Abdul Ghani, MD

Role: STUDY_DIRECTOR

Lecturer of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University

Rania M Lithy, MD

Role: STUDY_CHAIR

Lecturer of Endemic medicine and hepatogastroenterology. Faculty of medicine Cairo University

Hoda M abdel-Hamid, MD

Role: STUDY_CHAIR

Lecturer of Respiratory medicine. Faculty of medicine Cairo University

Mahmoud Wahba, MD

Role: STUDY_CHAIR

Lecturer of Internal Medicine Division of Gastroenterology, Kasr Alainy . Faculty of Medicine, Cairo University

Omar Ashoush, MD

Role: STUDY_CHAIR

Lecturer of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University

Mohamed Tharwat Hegazy, MD

Role: STUDY_CHAIR

Lecturer of Internal Medicine Department, Rheumatology and Clinical Immunology unit, Faculty of Medicine, Cairo University

Locations

Faculty of Medicine Cairo University

Cairo, , Egypt

Countries

Egypt

References

1.World Health Organization. Novel coronavirus (2019-nCoV): situation report-40. Available at: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200229-sitrep-40-covid-19.pdf. Accessed 29 February 2020.

Reference Type: BACKGROUND

Hoehl S, Rabenau H, Berger A, Kortenbusch M, Cinatl J, Bojkova D, Behrens P, Boddinghaus B, Gotsch U, Naujoks F, Neumann P, Schork J, Tiarks-Jungk P, Walczok A, Eickmann M, Vehreschild MJGT, Kann G, Wolf T, Gottschalk R, Ciesek S. Evidence of SARS-CoV-2 Infection in Returning Travelers from Wuhan, China. N Engl J Med. 2020 Mar 26;382(13):1278-1280. doi: 10.1056/NEJMc2001899. Epub 2020 Feb 18. No abstract available.

Reference Type: BACKGROUND

PMID: 32069388 (View on PubMed)

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

Reference Type: BACKGROUND

PMID: 32007143 (View on PubMed)

Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

Reference Type: BACKGROUND

PMID: 32171076 (View on PubMed)

Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.

Reference Type: BACKGROUND

PMID: 32105637 (View on PubMed)

Jin X, Lian JS, Hu JH, Gao J, Zheng L, Zhang YM, Hao SR, Jia HY, Cai H, Zhang XL, Yu GD, Xu KJ, Wang XY, Gu JQ, Zhang SY, Ye CY, Jin CL, Lu YF, Yu X, Yu XP, Huang JR, Xu KL, Ni Q, Yu CB, Zhu B, Li YT, Liu J, Zhao H, Zhang X, Yu L, Guo YZ, Su JW, Tao JJ, Lang GJ, Wu XX, Wu WR, Qv TT, Xiang DR, Yi P, Shi D, Chen Y, Ren Y, Qiu YQ, Li LJ, Sheng J, Yang Y. Epidemiological, clinical and virological characteristics of 74 cases of coronavirus-infected disease 2019 (COVID-19) with gastrointestinal symptoms. Gut. 2020 Jun;69(6):1002-1009. doi: 10.1136/gutjnl-2020-320926. Epub 2020 Mar 24.

Reference Type: BACKGROUND

PMID: 32213556 (View on PubMed)

Pan L, Mu M, Yang P, Sun Y, Wang R, Yan J, Li P, Hu B, Wang J, Hu C, Jin Y, Niu X, Ping R, Du Y, Li T, Xu G, Hu Q, Tu L. Clinical Characteristics of COVID-19 Patients With Digestive Symptoms in Hubei, China: A Descriptive, Cross-Sectional, Multicenter Study. Am J Gastroenterol. 2020 May;115(5):766-773. doi: 10.14309/ajg.0000000000000620.

Reference Type: BACKGROUND

PMID: 32287140 (View on PubMed)

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

Reference Type: BACKGROUND

PMID: 32031570 (View on PubMed)

9. Mo P, Xing Y, Xiao Y, et al. Clinical characteristics of refractory COVID-19 pneumonia in Wuhan, China. [published online ahead of print, 2020 Mar 16]. Clin Infect Dis 2020:ciaa270. doi:10.1093/ 54. cid/ciaa270

Reference Type: BACKGROUND

D'Amico F, Baumgart DC, Danese S, Peyrin-Biroulet L. Diarrhea During COVID-19 Infection: Pathogenesis, Epidemiology, Prevention, and Management. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1663-1672. doi: 10.1016/j.cgh.2020.04.001. Epub 2020 Apr 8.

Reference Type: BACKGROUND

PMID: 32278065 (View on PubMed)

Tian S, Chang Z, Wang Y, Wu M, Zhang W, Zhou G, Zou X, Tian H, Xiao T, Xing J, Chen J, Han J, Ning K, Wu T. Clinical Characteristics and Reasons for Differences in Duration From Symptom Onset to Release From Quarantine Among Patients With COVID-19 in Liaocheng, China. Front Med (Lausanne). 2020 May 12;7:210. doi: 10.3389/fmed.2020.00210. eCollection 2020.

Reference Type: BACKGROUND

PMID: 32574322 (View on PubMed)

Lu Y, Li Y, Deng W, Liu M, He Y, Huang L, Lv M, Li J, Du H. Symptomatic Infection is Associated with Prolonged Duration of Viral Shedding in Mild Coronavirus Disease 2019: A Retrospective Study of 110 Children in Wuhan. Pediatr Infect Dis J. 2020 Jul;39(7):e95-e99. doi: 10.1097/INF.0000000000002729.

Reference Type: BACKGROUND

PMID: 32379191 (View on PubMed)

13. World Health Organization. Clinical management of COVID-19: interim guidance. 2020, p.62.

Reference Type: BACKGROUND

Coronavirus Disease 2019 (COVID-19) Treatment Guidelines [Internet]. Bethesda (MD): National Institutes of Health (US); 2021 Apr 21-2024 Mar 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK570371/

Reference Type: BACKGROUND

PMID: 34003615 (View on PubMed)

World Medical Association Inc. Declaration of Helsinki. Ethical principles for medical research involving human subjects. J Indian Med Assoc. 2009 Jun;107(6):403-5. No abstract available.

Reference Type: BACKGROUND

PMID: 19886379 (View on PubMed)

Other Identifiers

1004

Identifier Type: -

Identifier Source: org_study_id